Lung cancer (Amsterdam, Netherlands) · 2025
Real-world efficacy and safety of amivantamab in EGFR exon-20-mutant non-small cell lung cancer in a French early-access program: Amexon 20 GFPC study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Pierret Thomas, Greillier Laurent, Guisier Florian, Daniel Catherine, Descourt Renaud, Galland Loick, Molinier Olivier, Decroisette Chantal, Cortot Alexis, Moreau Diane, Gamé Laurence Bigay, Wislez Marie, Cloarec Nicolas, Curcio Hubert, Delberghe Nicolas, Cadranel Jacques, Duchemann Boris, Toffart Anne Claire, Chouaïd Christos, Auliac Jean-Bernard
Аннотация
BACKGROUND: Amivantamab is a bispecific anti-EGFR-MET antibody approved to treat non-small cell lung cancers (NSCLCs) harbouring EGFR exon 20 insertions (EGFR-exon20ins).
METHODS: We conducted a retrospective, multicentre analysis of consecutive patients with EGFR-exon20ins NSCLC treated with ≥ 1 dose of amivantamab in a French early-access programme (09/03/2021-04/30/2022). The primary endpoint was real-world progression-free survival (rwPFS). Secondary endpoints included treatment duration, overall survival (OS), outcomes in patients with brain metastases (BMs), and safety.
RESULTS: Thirty-nine patients were included (median age: 60 years; 64.1 % female, 54 % never-smokers, 33.3 % with ECOG performance status (ECOG-PS) ≥ 2; 66.7 % with BMs at baseline). Amivantamab was administered as second-line therapy in 30 % and third-line or later in 70 %. Patients received a median of 10 doses (range: 1-47) over a median [95 % CI] of 3.4 [1.8-6.3] months. Among 37 evaluable patients, partial responses and disease control were achieved in 35 % [17 %-49 %] and 62 % [44 %-76 %], respectively; median response duration was 5.8 [2.3-11.9] months. In patients with BM, partial response occurred in 23 % and disease control in 69 %. After a median follow-up of 11.3 [8-16.7] months, median rwPFS and OS were 3.5 [2.6-5.8] and 11.3 [8-17.8] months, respectively. Outcomes were 2.8 [3.5-17.8] and 8.7 [3.5-17.8] months in patients with BMs, and 7.6 [1.6-13.5] and 16.2 [8.3-NR] months in those without BMs, respectively. Grade ≥ 3 adverse events occurred in 11 patients (28.2 %), mainly skin toxicity (12.8 %) and infusion reactions (5.1 %), leading to dose reductions in 17.9 % and permanent discontinuation in 10.3 %. On multivariate analysis, ECOG-PS ≥ 2 was the only negative prognostic factor for both rwPFS and OS.
CONCLUSION: Amivantamab demonstrated clinical activity in EGFR-exon20ins-NSCLC, including in patients with BM, with a manageable safety profile.
METHODS: We conducted a retrospective, multicentre analysis of consecutive patients with EGFR-exon20ins NSCLC treated with ≥ 1 dose of amivantamab in a French early-access programme (09/03/2021-04/30/2022). The primary endpoint was real-world progression-free survival (rwPFS). Secondary endpoints included treatment duration, overall survival (OS), outcomes in patients with brain metastases (BMs), and safety.
RESULTS: Thirty-nine patients were included (median age: 60 years; 64.1 % female, 54 % never-smokers, 33.3 % with ECOG performance status (ECOG-PS) ≥ 2; 66.7 % with BMs at baseline). Amivantamab was administered as second-line therapy in 30 % and third-line or later in 70 %. Patients received a median of 10 doses (range: 1-47) over a median [95 % CI] of 3.4 [1.8-6.3] months. Among 37 evaluable patients, partial responses and disease control were achieved in 35 % [17 %-49 %] and 62 % [44 %-76 %], respectively; median response duration was 5.8 [2.3-11.9] months. In patients with BM, partial response occurred in 23 % and disease control in 69 %. After a median follow-up of 11.3 [8-16.7] months, median rwPFS and OS were 3.5 [2.6-5.8] and 11.3 [8-17.8] months, respectively. Outcomes were 2.8 [3.5-17.8] and 8.7 [3.5-17.8] months in patients with BMs, and 7.6 [1.6-13.5] and 16.2 [8.3-NR] months in those without BMs, respectively. Grade ≥ 3 adverse events occurred in 11 patients (28.2 %), mainly skin toxicity (12.8 %) and infusion reactions (5.1 %), leading to dose reductions in 17.9 % and permanent discontinuation in 10.3 %. On multivariate analysis, ECOG-PS ≥ 2 was the only negative prognostic factor for both rwPFS and OS.
CONCLUSION: Amivantamab demonstrated clinical activity in EGFR-exon20ins-NSCLC, including in patients with BM, with a manageable safety profile.